Support Services

We secure and support the clinical Safety and efficacy of artificial intelligence medical software,
medical robot, and medical devices.

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Clinical trial

Introduction of clinical trial services

We provide services necessary from submission to closeout of the clinical trial of medical device, through the cooperation with various internal
and external specialized departments connected to our center.

Process of supporting clinical trial

  • STEP 01


  • STEP 02

    protocol development

  • STEP 03

    cost calculation

  • STEP 04

    protocol approval

  • STEP 05


  • STEP 06

    clinical trial

  • STEP 07

    clinical trial

Coverage of clinical trial service

Official inquiry from the MFDS

Official inquiry to confirm medical device applicability, class and classification

confirmation of the need for a clinical trial

Selection of institution and researcher

Institution selection and relevance review

researcher selection and relevance review

Preparation of a research plan

CRO quotation

Plan for study budget

protocol review

budget review and negotiation

MFDS / IRB communication

MFDS visit consultation, IDE application

IRB application for review

A contract conclusion

contract review and consignment of contract work

preparation of victim compensation rules and taking out insurance

Clinical trial operation

Investigational device management

project management

monitoring and document management

End of clinical trial

IRB end of trial report

Report of clinical study results

in connection with DM, a statistical analysis team